Medication Guide App

SUPREFACT NASAL SPRAY

Active substance: BUSERELIN ACETATE

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522095

notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
PACKAGE LEAFLET:
INFORMATION FOR THE USER

Suprefact® 100
micrograms
Nasal Spray Solution
Buserelin acetate

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to see or read?
Phone 0845 372 7101
for help

In this leaflet:
1. What Suprefact Nasal Spray is and what it is
used for
2. Before you use Suprefact Nasal Spray
3. How to use Suprefact Nasal Spray
4. Possible side effects
5. How to store Suprefact Nasal Spray
6. Further information
1. What Suprefact Nasal Spray
is and what it is used for

Suprefact Nasal Spray contains a medicine called
buserelin acetate. This belongs to a group of
medicines called gonadotropin releasing hormone
analogues. This is a synthetic version of a hormone
that occurs naturally in the body. It works by
lowering the production of sex hormones.
It is used to treat prostate cancer by lowering the
amount of the hormone “testosterone”.

2. Before you use Suprefact Nasal Spray
Before using Suprefact, your doctor should
assess your risk of developing diseases of heart
and blood vessels (cardiovascular disease),
diabetes mellitus and anaemia. If you develop
any of the above, you should be monitored and
treated accordingly.
Do not take this medicine and tell your
doctor if:
× You are allergic (hypersensitive) to:
– buserelin
– other similar medicines such as goserelin
– any of the other ingredients of Suprefact
Nasal Spray (listed in Section 6 below)
• Signs of an allergic reaction include: a rash,
swallowing or breathing problems, swelling of
your lips, face, throat or tongue
× You have a tumour that is not affected by
changes in hormone levels
× You have had an operation to remove your
testicles
Do not use if any of the above apply to you. If
you are not sure, talk to your doctor or pharmacist
before using Suprefact Nasal Spray.
Take special care with Suprefact
Nasal Spray
Check with your doctor or pharmacist before
using your medicine if:
s You have depression. There have been
reports of depression in patients taking
Suprefact Nasal Spray which may be severe.
If you are taking Suprefact nasal spray and
develop depressed mood, inform your
doctor.
s You have high blood pressure. Your blood
pressure must be checked regularly

Read all of this leaflet carefully before you
start taking this medicine
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your
doctor or pharmacist.
• This medicine has been prescribed for you. Do
not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you

s You have diabetes. You should check your
blood glucose levels regularly
s You have metabolic bone disease or have
additional risk factors for osteoporosis such as
chronic alcohol abuse, smoking, a family
history of osteoporosis or are on long term
therapy with anticonvulsants or corticosteroids
If you are not sure if any of the above apply to
you, talk to your doctor or pharmacist before
using Suprefact Nasal Spray.

Important information about some of the
ingredients of Suprefact Nasal Spray
Suprefact Nasal Spray contains benzalkonium
chloride. This may cause difficulty breathing,
wheezing or tightness in the chest
(bronchospasm).

Taking other medicines
Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines.
This includes medicines you buy without a
prescription, including herbal medicines. This is
because Suprefact Nasal Spray can affect the way
some other medicines work. Also some medicines
can affect the way Suprefact Nasal Spray works.
In particular, tell your doctor or pharmacist if you
are taking the following:
• medicines for diabetes

Using this medicine
• Your doctor will normally give you Suprefact
injection for seven days. The doctor will then
start you on the nasal spray on the 8th day of
your treatment.
• It is very important you use this medicine
regularly and space the doses out evenly
through the day
• This medicine can be used if you have a cold.
If you have a cold, blow your nose thoroughly
before using the spray. If you are using a nasal
decongestant wait at least 30 minutes after
using Suprefact Nasal Spray before using the
decongestant
• Your doctor will monitor your hormone levels
by taking regular blood samples
• If you feel the effect of your medicine is too
weak or too strong, do not change the dose
yourself, but ask your doctor

Pregnancy and breast-feeding
This medicine is intended for use in men.
However, there is another type of this medicine
which can be used in women. Women should not
use either type of this medicine if they are
pregnant or breast feeding.
Driving and using machines
You may feel dizzy, drowsy or have blurred
eyesight while using this medicine. If this
happens, do not drive or use any tools or
machines.

3. How to use Suprefact Nasal Spray
Always use Suprefact Nasal Spray exactly as your
doctor has told you. You should check with your
doctor or pharmacist if you are not sure.

How to use Suprefact Nasal Spray:
1. Preparing the spray
• Remove the screw cap from bottle
• Remove the metered-dose nebulizer from
transparent plastic container and take off
both protective caps
• Screw the nebulizer on to the bottle

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2. If you are using the spray for the first
time
• Hold the bottle upright
• Pump 5 to 8 times until an even spray is
produced. This initial pumping is for the
purpose of filling the system and testing
the spray. It should not be repeated after
the first use in order to avoid wasting the
medicine
3.




Using the spray
Keep the bottle upright
Bend your head slightly over the bottle
Spray the solution into the nose

4. After using the spray
• After use leave the nebulizer on the
bottle
• After replacing the protective cap on the
nebulizer, the spray bottle is best stored
in its transparent container in an upright
position
How much Suprefact Nasal Spray to use:
Treatment of Prostate Cancer:
• The usual dose is one spray in each
nostril six times each day.
• Use the spray:
• In the morning – before and after
breakfast
• At midday – before and after lunch
• In the evening – before and after
dinner
• Your doctor will tell you how long
to continue using this medicine

522095

SAP-Nr. (DMC): 522095

SRZ-Nr.: 503338

Code: 38

Schriftgröße: 9 Punkt

Druckfarben: Pantone Reflex Blue

Format 420 x 148 mm

Erstellt am: 22. Oktober 2013 / Version: 3 / Mac

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4. Possible side effects
If you use more Suprefact Nasal Spray than
you should
If you use more Suprefact Nasal Spray than you
should, tell a doctor or go to a hospital casualty
department straight away. Take the medicine pack
with you. This is so the doctor knows what you
have used. The following effects may occur:
feeling weak, headache, feeling nervous, hot
flushes, feeling dizzy, feeling sick, stomach pain,
swelling of the legs and breast pain.
If you forget to use Suprefact Nasal Spray
If you forget a dose, take it as soon as you
remember it. However, if it is nearly time for the
next dose, skip the missed dose. Do not take a
double dose to make up for a forgotten dose.
If you stop using Suprefact Nasal Spray.
Keep using Suprefact Nasal Spray until your doctor
tells you to stop. If you stop, your prostate cancer
may get worse.
Blood Tests
Using Suprefact Nasal Spray may affect the results
of some blood tests. In particular, Suprefact Nasal
Spray can change the level of liver enzymes and
fats in the blood (lipids) shown up in blood tests.
If you are going to have a blood test, it is
important to tell your doctor you are using
Suprefact Nasal Spray.
If you have any further questions on the
use of this product, ask your doctor or
pharmacist.

SAP-Nr. (DMC): 522095

Like all medicines, Suprefact can cause side
effects, although not everybody gets them.
Stop using Suprefact and see a doctor
or go to a hospital straight away if;
• You have an allergic reaction. The signs may
include: a rash, swallowing or breathing
problems, swelling of your lips, face, throat or
tongue
• You have leg pain, difficulty breathing or being
short of breath and chest pain. This could be
because of blood clots in your body and lungs
Tell your doctor straight away if you notice
any of the following serious side effects:
• You bruise more easily than usual. This could
be because of a blood problem called
‘thrombocytopenia’
• You get a lot of infections. Signs include fever,
sore throat or mouth ulcers. These could be
signs of a blood problem called leucopenia
• You have nose bleeds and a hoarse voice
• Changes in your sense of taste or smell
• You have severe headaches and eyesight
problems. This is very rare but if it happens it
could be due to tumours on the pituitary gland.
This gland is found at the base of the brain
• Your blood pressure becomes higher. This is
very rare but if it happens you may get
symptoms such as crushing chest pain,
confusion, problems with your eyesight,
tiredness and an uneven heartbeat
• You have problems passing water (urine)
• You have sharp pain or aching in your side in
the area between the ribs and the hips. These
could be signs of a swollen kidney
• You feel tired and your body is swollen. These
could be signs of fluid build up in the tissues
called lymphostasis

SRZ-Nr.: 503338

Code: 38

Tell your doctor or pharmacist if any of the
following side effects get serious or lasts
longer than a few days:
• Loss of sex drive (libido)
• Atrophy (shrinking) of the testes
• Bone or muscle discomfort such as shoulder
pain or stiffness or muscle weakness. If
Suprefact Nasal Spray is used for a long period
of time, it may increase the risk of you getting
a condition called ‘osteoporosis’. This is when
your bones are more likely to break
• Lowered tolerance to glucose which may lead
to worsening of existing diabetes
• Changes in body weight, changes in appetite
and increased thirst
• Mood changes such as feeling depressed or
worsening of depression and feeling anxious.
Mood changes, depression
• Frequency: Long term use: common
Short term use: Uncommon
• Feeling nervous, dizzy, tired or drowsy
• Headache and disturbed sleep
• Problems with memory and concentration
• Unusual skin sensations such as numbness,
tingling, pricking, burning or creeping on the
skin. This can feel like ‘pins and needles’
(usually in the arms and legs) and is called
paraesthesia
• Dry eyes (possibly leading to eye irritation in
people who wear contact lenses), blurred
eyesight, feeling of pressure behind the eyes
• Hearing problems such as ringing in the ears
(tinnitus)
• Very fast, uneven or forceful heartbeat
(palpitations)
• Facial swelling (puffiness) due to water
retention which may also cause swollen arms
or legs

Schriftgröße: 9 Punkt

• Feeling or being sick, stomach ache, pain in
the lower abdomen, diarrhoea or
constipation
• Dry skin or acne or hot flushes
• Hair grows more than normal (including body
and facial hair)
• Hair loss (including body or facial hair)
• Splitting of nails
• Increase in breast size or breast tenderness
• Changes in the level of liver enzymes, fats
(lipids) and a substance called ‘bilirubin’ in the
blood shown up in blood tests
Reporting of side effects
United Kingdom
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can
also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide
more information on the safety of this
medicine.
Malta
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can
also report side effects directly (see details
below). By reporting side effects you can help
provide more information on the safety of this
medicine.
ADR Reporting, The Medicines Authority,
Post-Licensing Directorate, 203 Level 3,
Rue D'Argens, GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt

Druckfarben: Pantone Reflex Blue

5. How to store Suprefact Nasal Spray
Keep this medicine in a safe place where children
cannot see or reach it.
Do not use Suprefact Nasal Spray after the expiry
date which is stated on the bottle. The expiry date
refers to the last day of that month.
Store below 25 °C. Do not freeze.
Once opened the product should be used within 1
week. Any remaining spray should be disposed
of after this time.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer
required. These measures will help to protect the
environment.

Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Sanofi
One Onslow Street, Guildford,
Surrey,
GU1 4YS, UK
Tel: 0845 372 7101
email: uk-medicalinformation@sanofi.com
Manufacturer
Sanofi-Aventis Deutschland GmbH,
Industriepark Höchst,
65926 Frankfurt am Main,
Germany
This package contains a metered dose nebulizer

6. Further Information
What Suprefact Nasal Spray contains
• Each spray dose contains 100 micrograms of
the active substance, buserelin as buserelin
acetate
• The other ingredients are citric acid
monohydrate, sodium citrate dihydrate, sodium
chloride, benzalkonium chloride and water for
injections.
What Suprefact Nasal Spray looks like and
contents of the pack
Suprefact Nasal Spray is available in boxes
containing four bottles and four spray pumps.
Each bottle contains 10 grams of solution.

Manufacturer: Sanofi-Aventis Deutschland GmbH,
65926 Frankfurt am Main, Germany
This leaflet does not contain all the information
about your medicine. If you have any questions or
are not sure about anything, ask your doctor or
pharmacist.
This leaflet was last revised in
October 2013.
© sanofi, 1997-2013

2

Format 420 x 148 mm

Erstellt am: 22. Oktober 2013 / Version: 3 / Mac

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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